Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV4 | HPV (GARDASIL) | MERCK & CO. INC. | 1 | — | — |
acute psychosis; depression; condition worse; white blood cell counts elevated; potassium levels were elevated; Autoimmune Injuries; autonomic dysfunction/headaches, insomnia/ chest pain/ high blood pressure/high heart rate/ severe arrhythmia, tachycardia, hypertension/ chronic fatigue, insomnia, chronic headaches, vision change; protein in the central spinal fluid; low vitamin D; low albumin; AST were elevated; lost 30 pounds over a month's time/extreme weight-loss; fever; ALT were elevated; low thyroid functioning; joint pain; suicidal thoughts; Information has been received from a lawyer regarding a case in litigation and referred to a male adolescent/minor patient (pt). His other medical history, concurrent conditions and concomitant therapies were not provided. On 11-Dec-2019 (at the age of 15 years old), the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), as recommended by his health care provider/doctor, with his mother's consent, for prophylaxis (also reported as for preventing cervical cancer). Shortly after receiving the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, pt started having severe headaches, insomnia, and depression. He was taken back to the pediatrician who had administered the vaccination and was told that he would be fine. Instead of being fine, his condition deteriorated. Pt started to experience chest pain and acute psychosis. He did not feel well enough to play with his friends or play his video games. Pt was taken to the emergency room (ER) and was sent to two different psychiatric hospitals and placed on antipsychotic medications, but the medications made his condition worse. His white blood cell counts and potassium levels were elevated. A lumbar puncture was done that showed protein in the central spinal fluid, low vitamin D, low albumin, his liver aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were elevated and steadily rising, and he had low thyroid functioning. He experienced high blood pressure and a high heart rate. Pt also suffered severe arrhythmia, tachycardia, hypertension, and lost 30 pounds over a month's time. He developed chronic fatigue. Although extremely fatigued, he had difficulty sleeping/insomnia and, as a result, lost the ability to complete day-to-day activities. Pt also developed chronic headaches, vision changes, including "floaters" and light sensitivity. He developed feelings of cold and then burning sensations in his arms and legs as well as joint pain. Following the quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection, pt spent two months in the hospital. He was unable to attend school in person and he had to be homeschooled. As the months progressed, so did pt's symptoms. He was seen by multiple physicians and specialists for his complaints which now included: headaches, insomnia, depression, chest pain, acute psychosis, suicidal thoughts, fever, elevated white blood cell counts, elevated potassium, low vitamin D, low albumin, elevated liver AST and ALT, low thyroid functioning, high blood pressure, high heart rate, severe arrhythmia, tachycardia, hypertension, extreme weight-loss, chronic fatigue, insomnia, chronic headaches, vision changes, light sensitivity, feeling of coldness and burning sensations in arms and legs, joint pain, brain fog, inability to concentrate, and memory troubles. As a result of his post-Gardasil symptoms, pt had been unable to engage in activities that a normal young person would enjoy. Based upon his chronic and severe post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been diagnosed with various medical conditions, including but not limited to, autonomic dysfunction, chronic fatigue, and neuropsychiatric complications. Pt contended that his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injection caused him to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to autonomic dysfunction, chronic fatigue, and neuropsychiatric complications, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. It was contended that his quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused pt to sustain serious and debilitating autoimmune, autonomic and neurological injuries (Autoimmune disorder), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries and permanent emotional injuries, including pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, and future symptoms and harms associated with his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of all events was considered to be not recovered. The lawyer considered all events to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The lawyer considered all events to be disabling / incapacitating. This is one of several reports received from same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-05-07 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-05-05 , Classification : DMC, Attachment description : Legal , Safety case number :
Test Name: albumin; Result Unstructured Data: low albumin; Test Name: Aspartate Aminotransferase; Result Unstructured Data: liver AST was elevated and steadily rising; Test Name: Alanine Aminotransferase; Result Unstructured Data: alanine aminotransferase (ALT) was elevated and steadily rising; Test Name: thyroid functioning; Result Unstructured Data: low thyroid functioning; Test Name: blood pressure; Result Unstructured Data: high blood pressure/hypertension; Test Name: heart rate; Result Unstructured Data: high heart rate/tachycardia; Test Name: weight; Result Unstructured Data: lost 30 pounds over a month's time; Test Name: white blood cell counts; Result Unstructured Data: elevated; Test Name: potassium level; Result Unstructured Data: elevated; Test Name: lumbar puncture; Result Unstructured Data: protein in the central spinal fluid; Test Name: vitamin D; Result Unstructured Data: low vitamin D